Real-life effectiveness evaluation of budesonide/formoterol (BF) Spiromax for the management of asthma and COPD

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Spiromax, Symbicort Turbohaler, Seretide Accuhaler
• Medical condition to be studied:
  Asthma

  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Adult Asthma and COPD patients who were on either Symbicort® Turbohaler® or Seretide® Accuhaler® during their baseline period and received a continued prescription for same inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) FDC or were changed to DuoResp® Spiromax®.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma and Chronic obstructive pulmonary disease patients
• Estimated number of subjects:
  6400

Study design details

• Main study objective:
  To characterise patients who change to BF Spiromax from another FDC ICS/LABA and evaluate acceptability, and the real-life effectiveness and cost-effectiveness of BF Spiromax.
• Outcomes:
  Risk Domain Control (binary), Comparison of severe exacerbation rate, treatment stability, SABA usage, and lower respiratory-related hospitalisations.Cost-effectiveness in relation to asthma- and COPD-related total and disaggregated respiratory therapy prescription costs, primary care consultation costs, and respiratory-related hospitalisation costs.
• Data analysis plan:
  Statistically significant results will be defined as p<0.05 and trends as 0.05<p<0.10. Summary statistics will be produced for all baseline and outcome variables, for each study phase cohort. In phase 4, patients will be uniquely matched on demographics and key measures of disease severity to minimise confounding. Matching variables will be selected based on clinical review and baseline differences between the treatment groups. Matching will be conducted separate for asthma and COPD patients. The primary outcome will be analysed using conditional logistic regression, separately for asthma and COPD patients. Secondary outcomes will be analysed using conditional poisson, logistic, and ordinal logistic regression as appropriate, separately for asthma and COPD patients.

Documents

Study results

170116_R00615_Spiromax_ph34_final_report_V1_3